Trial Outcomes & Findings for Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients (NCT NCT00123123)

Results Overview

Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide. Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli). Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

175 participants

Primary outcome timeframe

Every 48 hours until discharge

Results posted on

2021-05-05

Participant Flow

Subjects were recruited from 1 March, 2004 until 30 November, 2007. Subjects were recruited from patients admitted to the ICU of the Erie County Medical Center (ECMC) who were mechanically ventilated. This ICU provides trauma, burn care, and rehabilitation and is an affiliated teaching facility for the State University of New York at Buffalo.

Participant milestones

Participant milestones
Measure	Placebo Vehicle control twice a day (oral rinse)	Chlorhexidine/Placebo Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day	Chlorhexidine chlorhexidine 1 oz oral rinse twice a day
Overall Study STARTED	59	58	58
Overall Study COMPLETED	59	58	58
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=59 Participants Vehicle control twice a day (oral rinse)	Chlorhexidine/Placebo n=58 Participants Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day	Chlorhexidine n=58 Participants chlorhexidine 1 oz oral rinse twice a day	Total n=175 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	58 Participants n=7 Participants	58 Participants n=5 Participants	175 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	50.0 years STANDARD_DEVIATION 22.5 • n=5 Participants	44.8 years STANDARD_DEVIATION 19.9 • n=7 Participants	47.6 years STANDARD_DEVIATION 19.1 • n=5 Participants	48.0 years STANDARD_DEVIATION 20.8 • n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	52 Participants n=4 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	43 Participants n=7 Participants	44 Participants n=5 Participants	123 Participants n=4 Participants
Region of Enrollment United States	59 participants n=5 Participants	58 participants n=7 Participants	58 participants n=5 Participants	175 participants n=4 Participants

PRIMARY outcome

Timeframe: Every 48 hours until discharge

Population: All tests were carried out using intent-to-treat analysis, with two-sided tests with a significance level of 0.05. Baseline comparisons between groups were made by analysis of variance (ANOVA) and/or the chi-squared test, as appropriate.

Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide. Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli). Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Vehicle control twice a day (oral rinse)	Chlorhexidine/Placebo n=58 Participants Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day	Chlorhexidine n=58 Participants chlorhexidine 1 oz oral rinse twice a day
Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours	7 CFU/mL Standard Deviation 2	7.1 CFU/mL Standard Deviation 1.9	5.1 CFU/mL Standard Deviation 2

SECONDARY outcome

Timeframe: 48 hours

The CPIS score was calculated as follows: 1) Fever: 0 (36.5 to 38.4°C), 1 (38.5 to 39), 2 (\<36.0 OR \>39.0); 2) Leukocytosis: 0 (4000 to 11,000 white blood cells per mm3 of blood), 1 (11,000 to 17,000), 2 (\>17,000); 3) New infiltrate: 0 = None, 1 = Patchy, 2 = Localized; 4) Secretions: 0 = None to minimal, 1 = moderate, 2 = large amount; and 5) PaO2/ FiO2: 0 = more than 330 and 2 = less than 330. Total scores for the subscales can range from 0-10, with lower scores indicating better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Vehicle control twice a day (oral rinse)	Chlorhexidine/Placebo n=58 Participants Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day	Chlorhexidine n=58 Participants chlorhexidine 1 oz oral rinse twice a day
Clinical Pulmonary Infection Score (CPIS) at 48 Hours	2.5 units on a scale Standard Deviation 1	2.5 units on a scale Standard Deviation 0.9	2.4 units on a scale Standard Deviation 1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chlorhexidine/Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chlorhexidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Frank A. Scannapieco

University at Buffalo

Phone: 716-829-3373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place